(267 days)
StabiliT ER Bone Cement:
The StabiliT ER Bone Cement is intended for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
StabiliT Vertebral Augmentation System (for use with StabiliT ER * Bone Cement):
The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of StabiliT ER Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
StabiliT ER* Bone Cement:
The StabiliT ER Bone Cement is two-component PMMA bone cement with a powder component and a liquid component.
StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement):
StabiliT Vertebral Augmentation System is a motorized, microprocessor controlled bone cement delivery system intended for percutaneous delivery of bone cement in vertebroplasty or kyphoplasty procedures that allows for warming of the cement during cement delivery.
This document describes the 510(k) premarket notification for the StabiliT ER Bone Cement and StabiliT Vertebral Augmentation System. While it confirms the device's substantial equivalence to predicate devices based on in-vitro testing and biocompatibility, it does not contain information typically associated with acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML product or a complex medical device undergoing extensive clinical trials for performance metrics.
Specifically addressing your numbered points based on the provided text:
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A table of acceptance criteria and the reported device performance:
The document mentions "Results of in-vitro testing (material, performance, mechanical, electrical) demonstrate that the StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) functioned as intended and the results of tests were as expected." However, it does not provide a specific table of acceptance criteria or detailed quantitative performance metrics. It only states that the devices functioned as intended and meet the requirements of ISO 10993-1 for biocompatibility. -
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the document. The testing described is "in-vitro testing," which generally refers to laboratory tests, not human or animal clinical trials. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable/not provided as the testing was in-vitro (material, mechanical, electrical performance, biocompatibility) and did not involve expert-established ground truth for a diagnostic or AI/ML-driven device. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable/not provided for the same reasons as point 3. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable/not provided. The device in question is a bone cement and a delivery system for vertebroplasty/kyphoplasty. It is a physical medical device, not an AI/ML diagnostic or assistive technology that would involve human readers. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided. The device is a physical medical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this type of device typically relates to engineering specifications and material science standards (e.g., tensile strength, setting time, biocompatibility standards). The document states the device "meet the requirements of ISO 10993-1" for biocompatibility and "functioned as intended" based on in-vitro material, performance, mechanical, and electrical testing. However, no specific details on the metrics or how "ground truth" was established are provided beyond these general statements. -
The sample size for the training set:
This information is not applicable/not provided as the device is not an AI/ML product requiring a training set. -
How the ground truth for the training set was established:
This information is not applicable/not provided as the device is not an AI/ML product requiring a training set.
Summary of Acceptance Criteria and Device Performance (as much as can be extracted):
| Acceptance Criteria Category | Reported Device Performance | Study Type |
|---|---|---|
| Material Performance | Functioned as intended | In-vitro |
| General Performance | Functioned as intended | In-vitro |
| Mechanical Performance | Functioned as intended | In-vitro |
| Electrical Performance | Functioned as intended | In-vitro |
| Biocompatibility | Meets ISO 10993-1 requirements | In-vitro |
Overall Study Information:
- Study Name/Type: In-vitro testing (material, performance, mechanical, electrical, and biocompatibility).
- Sample Size (Test Set): Not specified. (Applies to in-vitro samples of the cement and device components)
- Data Provenance: Not specified, but generally refers to laboratory testing environment.
- Experts for Ground Truth: Not applicable (in-vitro engineering and material testing).
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable (device is not an AI/ML diagnostic/assistive technology).
- Standalone Performance: Not applicable (device is not an algorithm).
- Type of Ground Truth: Adherence to established engineering specifications and material science standards (e.g., ISO 10993-1 for biocompatibility).
- Sample Size (Training Set): Not applicable (device is not an AI/ML product).
- Training Set Ground Truth Establishment: Not applicable.
The document primarily focuses on establishing "substantial equivalence" to predicate devices based on shared intended use, indications, technological characteristics, and principles of operation, supported by in-vitro tests that showed the device "functioned as intended" and met biocompatibility standards. It does not provide detailed performance metrics or clinical study results that typically accompany acceptance criteria for more complex medical devices or AI/ML products.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”